TECHNICAL PROBLEMS POSED BY THE PRIOR ART
Various medical procedures require the transfer of fluid from one fluid-containment system or fluid-conducting system to another fluid-containment system or fluid-conducting system. Typically, one of the two systems includes a container for a bulk supply of liquid, such as a bulk supply of a reconstituted, liquid, chemotherapeutic drug. The other system, which can be as simple as a syringe, may be connected to the first system for only a short period of time, or intermittently, to facilitate the withdrawal of a desired amount or dose of the liquid for administration or transmission to a patient.
In those medical applications where the first system includes a container for a bulk supply of a toxic liquid, it is desirable, if not necessary, to prevent inadvertent exposure of personnel to the toxic liquid. For example, a hospital pharmacy may prepare highly toxic, chemotherapeutic drugs for use in treating cancer patients. Typically, a vial of a highly concentrated, toxic drug is received from the pharmaceutical supplier by the hospital pharmacy, and the hospital personnel then admix the concentrated drug with a suitable diluent to provide a bulk reconstituted supply having a reduced concentration or effective dose per unit volume that permits the administration of a prescribed amount or volume directly to the patient.
The preparation of the bulk reconstituted, liquid drug is typically carried out in a protective environment, such as in a laminar flow hood which is specially designed to maintain a negative pressure within the hood so as to prevent the escape of toxic vapors.
The bulk reconstituted, liquid drug is usually stored in a suitable container which may be a flexible, thermoplastic, sealed bag. A suitable discharge structure, dispensing structure, or fitment is typically provided on the bulk container to accommodate withdrawal of a desired amount of the liquid from the container. It is, of course, desirable to ensure that the means for withdrawing a prescribed amount of the toxic liquid drug will not result in spills or leaks from the bulk container.
Accordingly, it would be advantageous to provide a barrier system which could be employed with a container of a bulk supply of a toxic drug and which would function to contain a leak or leaks of the liquid drug from the container, or from associated connections thereto, so as to prevent exposure of personnel to the drug.
It would also be desirable to provide such a barrier system with means for accommodating its disposition in association with, or its connection to, the bulk supply container in a manner that can be relatively easily and quickly effected.
It would also be beneficial if such a barrier system could be provided with a structure that would accommodate movement or transport of the bulk supply from one location to another while still maintaining the efficacy of the barrier system against leakage.
Further, it would be desirable to provide such a barrier system with means for accommodating withdrawal of the bulk reconstituted, liquid drug by means of a suitable, conventional syringe, especially a syringe having a luer fitment.
It would also be advantageous for such a barrier system to function to prevent inadvertent injection of the liquid drug, or other material, back into the bulk container so as to reduce the probability of contamination of the bulk supply.
In addition, it would be beneficial if the barrier system could accommodate the use of a syringe to withdraw the liquid drug from the bulk supply and to pump a desired volume of the liquid drug into a selected conduit for administration to a patient or for delivery to another container or containment system.
When a bulk container of liquid is employed for supplying small quantities or doses of the liquid drug via withdrawal by a syringe, it would be desirable to provide means for accommodating the aspiration or discharge from the syringe of an excess amount of the liquid, or of a portion of the liquid in which an air bubble is entrained, that may have been drawn into the syringe. It would be desirable to provide such a capability regardless of whether or not the bulk supply of liquid is toxic.
Accordingly, it would be desirable to provide a suitable receiving compartment or receptacle for excess liquid and/or for a mixture of liquid and air, in conjunction with a syringe-operated transfer or withdrawal system operable on a bulk supply. It would be beneficial if such a receptacle could be provided as a unitary or integral part of the withdrawal system and could also be adapted for use with a barrier system that prevents exposure of personnel to leakage.
Further, in view of the dangers associated with toxic drugs, contamination, and infection, it would be desirable to provide a barrier system and/or receptacle system which would facilitate its use as a disposable item. To this end, such a system or systems should be relatively inexpensive. Accordingly, such systems should incorporate an improved component design that accommodates relatively simple manufacturing processes and assembly processes to keep the total cost as low as possible.
The systems should also function to effectively seal at connection points or attachment points to prevent leakage of fluids and to prevent ingress of airborne or liquid-carried contaminants.
Additionally, the systems should preferably function effectively with a variety of fluids throughout a range of fluid pressures.
Advantageously, the systems should have a suitably long shelf life and active use life. Further, such systems should preferably be adaptable to function effectively after repeated connections to a syringe.